[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":12,"responsibleParty":34,"collaborators":36,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":12,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":77,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":12},{"fullName":5,"class":6},"University College Dublin","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Block A (Usual care phases)","NO_INTERVENTION","The comparator is usual care (Block A women) as provided at each participating maternity hospital",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Block B (Intervention phase)","EXPERIMENTAL","Women identified as being at risk and likely to benefit from lifestyle intervention will be invited to participate in the B2B\\&Me+ programme through one of four randomly allocated referral methods (randomisation at site level) that will be rotated every 2 weeks:\n\ni. Point-of-care (POC) active referral: Women will be directly offered the programme after their appointment, and they will be supported to commence the app sign-up process ii. POC with follow-up phone call: As above plus follow-up call within 48 hours to support enrolment iii. Leaflet with follow-up call: Women will receive an information leaflet about the programme and sign-up process plus a follow-up call within 48 hours to support enrolment iv. Leaflet provided: Women will receive only an information leaflet about the programme and sign-up process",[18],"Behavioral: Life Style Intervention",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Life Style Intervention","The intervention consists of seven related components:\n\nI. A Bluetooth-enabled weighing scale that syncs with the app to facilitate self-monitoring of weight.\n\nII. Synchronous coaching sessions conducted on a 1:1 basis between the mHealth coach and participants. There will be 2 synchronous sessions, the first at enrolment and the second between 6-8 weeks postpartum. These sessions typically last 45-50 minutes in length with a follow-up summary video message of the goals discussed and, at the beginning of the mother's journey, the establishing of a change agreement. This is mediated through the live-video feature in the B2B\\&Me+ mHealth coaching app, but the length and thus number of these sessions is determined by the woman. If the woman is diagnosed with GDM, there will be an opportunity for a third 15-minute synchronous coaching session to review and adjust any lifestyle goals to align with the individual's diabetes management plan.\n\nIII. Asynchronous mHealth coaching that uses a combi",[14],[26],{"name":27,"affiliation":5,"role":28},"Sharleen O'Reilly","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","00353 1 716 7777","sharleen.oreilly@ucd.ie",{"type":35,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[37,39,41,44,46,48,50,52],{"name":38,"class":6},"National Maternity Hospital, Ireland",{"name":40,"class":6},"Aarhus University Hospital",{"name":42,"class":43},"Liva Healthcare A\u002FS","UNKNOWN",{"name":45,"class":6},"Western Norway University of Applied Sciences",{"name":47,"class":6},"University of Agder",{"name":49,"class":6},"Pomeranian Medical University Szczecin",{"name":51,"class":6},"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental",{"name":53,"class":6},"Deakin University","100607489","implementation-and-evaluation-of-bump2baby-and-me-programme-for-gestational-diabetes-mellitus-in-routine-maternity-care-setting-100607489",false,"NCT07189221","Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.","BUMP2BABY & ME+ (B2B&ME+): A Multi-Country, European Implementation Project to Reduce Adverse Birth Outcomes, Improve Maternal and Child Health and Reduce Non-Communicable Disease Risk","B2B&ME+","Inclusion Criteria:\n\n* Pregnant women attending their first\u002Fearly antenatal appointments at participating sites\n* Gestation less than 24 weeks at enrolment\n* Age 18 years or older\n* Ability to provide informed consent\n\nAdditional for the intervention group (Block B):\n\n* Identified as higher risk for GDM using the MMLGDST\n* Ownership of a smartphone compatible with the B2B\\&Me+ app\n\nExclusion Criteria:\n\n* 24 weeks gestation or higher\n* Multiple pregnancy (twins, triplets, etc.)\n\nAdditional for the intervention group (Block B):\n\n* Participation in another health behaviour change intervention study during pregnancy\n* Inability to understand the language of the intervention (English in Ireland, Spanish in Spain, Norwegian in Norway, Polish in Poland)\n* Severe mental illness, drug or alcohol abuse that would impair ability to participate\n* Cancer (not in remission)\n* Myocardial infarction in the last three months\n* Pre-existing diabetes (Type 1 or Type 2), or early GDM.\n* Not owning a smartphone capable of hosting the intervention app","FEMALE","18 Years",{"count":65,"type":66},3600,"ESTIMATED","INTERVENTIONAL",[69],"NA","Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants. While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. This project looks to address this gap by exploring the effectiveness of the B2B\\&Me+ programme within regular maternity services across four European countries and how best to implement it.\n\nWomen identified as being at higher risk of developing GDM using a GDM screening tool will receive access to the smartphone application that connects them with their health coach, who will provide personalised support about healthy eating, physical activity, mental wellbeing, and infant care from early pregnancy until 9 months after birth. The participants will be randomised initially to a specific referral pathway for the intervention.",[72],"Gestational Diabetes Mellitus (GDM)",[74,75,76],"Pregnancy","GDM","Lifestyle Intervention","NOT_YET_RECRUITING","2025-09-16",{"date":80,"type":81},"2025-09-23","ACTUAL",{"date":83,"type":66},"2025-12-01",{"date":85,"type":66},"2028-05-31",{"name":5,"class":6}]